ClinicalTrials.gg
Enrolling by invitationNCT00047996Updated Oct 26, 2026

Blood Collection for Research Related to Certain Diseases Involving Blood Vessels

An observational study in Sickle Cell Disease, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 61 studies in Anemia, Sickle Cell by National Heart, Lung, and Blood Institute (NHLBI) — 5 open to participants now, 13 under way, none of them phase 3. Anemia, Sickle Cell · National Heart, Lung, and Blood Institute (NHLBI).

Planned enrollment
3rd of 21
2,000 · median 119
Started
2002
with 1 other
Observational
29 of 61
1 open now
Registered
23rd of 61
by date

Among the 61 studies in Anemia, Sickle Cell by National Heart, Lung, and Blood Institute (NHLBI), this one is the 3rd largest by planned enrollment of the 21 observational ones that give a count, is one of 2 that started in 2002, is one of 29 observational ones, and was the 23rd registered.

Anemia, Sickle Cell

1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.

Browse Anemia, Sickle Cell studies →

Open to participants now

5 of the 61 studies in Anemia, Sickle Cell by National Heart, Lung, and Blood Institute (NHLBI) are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

Who these studies take

Of the 177 Anemia, Sickle Cell studies recruiting now, 64 (36%) set no upper age limit and 97 (55%) stop at 75 or younger; 127 take children under 18; 29 take healthy volunteers.

This study: 18 Years to 100 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 61 studies in Anemia, Sickle Cell by National Heart, Lung, and Blood Institute (NHLBI), or all of them as a file.
02

Study summary

The collection of human specimens from both patients and healthy volunteers is necessary for the development of laboratory assays to further basic and clinical research studies. This protocol defines the purposes for which specimens will be collected and establishes general conditions under which sample collection will be performed.

Read the detailed description

The collection of human specimens from both patients and healthy volunteers is necessary for the development of laboratory assays to further basic and clinical research studies. This protocol defines the purposes for which specimens will be collected and establishes general conditions under which sample collection will be performed.

03

Conditions studied

  • Sickle Cell Disease

Keywords

  • DNA
  • Endothelial Function
  • Leukocyte Gene Expression
  • RNA
  • Natural History
  • Sickle Cell
  • Coronary Artery Disease
  • CAD
  • Healthy Volunteer
  • HV
04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Normal subjects, Male/Female

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Males or females of age 18 years and older can be included in the study.

Exclusion criteria

EXCLUSION CRITERIA:

Individuals without sickle cell disease or other chronic anemias who wish to donate blood will be excluded if the is less than 10 g/dL for women or less than 12g/dL for men.

Individuals with sickle cell disease or other chronic anemias will be excluded from donating blood samples if the hemoglobin is less than 6 g/dL.

A participant s most recent CBC result, obtained in the past 12 months, will be used to determine eligibility.

There are no exclusion criteria for participants donating urine.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)

Groups and cohorts

  • Group1

    Clinical Center Patients, Healthy Volunteers

06

What researchers measure

Primary outcomes

  1. evaluating the role of nitric oxide, inflammatory mediators, and endothelial function in inflammatory diseases of the vasculature such as sickle cell disease, coronary artery disease, pulmonary vascular or advanced lung disease, malaria, and sep...

07

Study locations

2 sites
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
  • INOVA Fairfax Hosptial
    Fairfax, Virginia 22042, United States
08

References and documents

Publications

  • Tumburu L, Ghosh-Choudhary S, Seifuddin FT, Barbu EA, Yang S, Ahmad MM, Wilkins LHW, Tunc I, Sivakumar I, Nichols JS, Dagur PK, Yang S, Almeida LEF, Quezado ZMN, Combs CA, Lindberg E, Bleck CKE, Zhu J, Shet AS, Chung JH, Pirooznia M, Thein SL. Circulating mitochondrial DNA is a proinflammatory DAMP in sickle cell disease. Blood. 2021 Jun 3;137(22):3116-3126. doi: 10.1182/blood.2020009063. PubMed 33661274 ↗
09

Timeline

6 registry updates since Sep 25, 2026

Started Nov 2002 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2006
First posted
Oct 23, 2002
StartActual
Nov 4, 2002
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: description and verification date
6 updates, last Oct 26, 2026
Show all 6 updates
  1. Oct 26, 2026
    Minor edits only
    + 1 other change: description
  2. Oct 21, 2026
    Minor edits only
    + 1 other change: verification date
  3. Oct 16, 2026
    Minor edits only
    + 1 other change: verification date
  4. Oct 13, 2026
    Minor edits only
    + 1 other change: description
  5. Oct 8, 2026
    Minor edits only
    + 1 other change: description
  6. Oct 2, 2026
    Minor edits only
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00047996
Responsible party
Sponsor
First posted
Oct 23, 2002
Start date
Nov 4, 2002
Last update
Oct 26, 2026

Study contacts

Swee Lay Thein, M.D.
principal investigator · National Heart, Lung, and Blood Institute (NHLBI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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